Unique ID issued by UMIN | UMIN000006528 |
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Receipt number | R000007698 |
Scientific Title | Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies |
Date of disclosure of the study information | 2011/10/13 |
Last modified on | 2016/11/16 08:56:16 |
Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
<CCOG-1104 (C3-02)>
Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Multicenter phase II study of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
<CCOG-1104 (C3-02)>
Japan |
Colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy and safety of adding bi-weekly cetuximab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Safety,Efficacy
Progression free survival
One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
adding bi-weekly cetuximab to oral S-1 therapy
20 | years-old | <= |
Not applicable |
Male and Female
(1) Histopathologically confirmed colorectal cancer
(2) Unresectable advanced colorectal cancer patients who have failed prior oxaliplatin and irinotecan-based therapies
(3) Measurable or evaluable disease (RECIST ver.1.1.)
(4) Colorectac cancer with Kras wild type gene
(5) Age of 20 years or older
(6) ECOG performance status 0-1
(7) Alife expectancy greater than 3 months
(8) Written informed concent
(9) Adequate organ function
(1) Patient who had treated by EGFR inhibitors
(2) Uncontrolled infection.
(3) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
(4) Severe lung disease.
(5) Interstitial lung disease or pulmonary fibrosis.
(6) Severe liver disease.
(7) Severe renal failure, or urinary protein (more than 2+).
(8) Previous history of severe drug-induced allergy
(9) ileus, bowel obstruction
(10) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
(11) History of active double cancer.
(12) Massive pleural effusion or ascites that required drainage.
(13) Brain metastasis
(14) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(15) Not appropriate for the study at the physician's assessment.
30
1st name | |
Middle name | |
Last name | Goro Nakayama |
Nagoya University Gradeate School of Medicine
Department of Gastroenterology
65,Turumaityou,Syouwaku,Nagoya city,Aichi prefecture
052-744-2250
goro@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Norifumi Hattori |
Nagoya University Gradeate School of Medicine
Department of Gastroenterology
65,Turumaityou,Syouwaku,Nagoya city,Aichi prefecture
052-744-2250
http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
norifumi@med.nagoya-u.ac.jp
Chubu Clinical Oncology Group (CCOG)
None
Self funding
NO
2011 | Year | 10 | Month | 13 | Day |
Unpublished
No longer recruiting
2011 | Year | 09 | Month | 26 | Day |
2011 | Year | 10 | Month | 01 | Day |
2016 | Year | 09 | Month | 01 | Day |
2011 | Year | 10 | Month | 12 | Day |
2016 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007698
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